Vaccine failure

Confirmed or suspected vaccine failure.

Confirmed clinical vaccine failure

Occurrence of the specific vaccine-preventable disease in a person who is appropriately and fully vaccinated taking into account the incubation period and the normal delay for the protection to be acquired as a result of immunisation (see CIOMS-WHO20).

Suspected clinical vaccine failure

Occurrence of disease in an appropriately and fully vaccinated person, but the disease is not confirmed to be the specific vaccine-preventable disease, e.g. disease of unknown serotype in a fully vaccinated person (based on CIOMS-WHO20).

Confirmed immunological vaccine failure

Failure of the vaccinated person to develop the accepted marker of protective immune response after being fully and appropriately vaccinated, as demonstrated by having tested or examined the vaccinated person at an appropriate time interval after completion of immunisation (based on CIOMSWHO20 .

Suspected immunological vaccine failure

Failure of the vaccinated person to develop the accepted marker of protective immune response after being fully and appropriately vaccinated, but with the testing or examination of the vaccinated person done at an inappropriate time interval after completion of immunisation (based on CIOMS-WHO20). For interpreting what means appropriately vaccinated, consider the explanatory note for Immunisation error-related reaction.